Comparison of Once-daily Versus Twice-daily Injection of Insulin Detemir in Children with Type 1 Diabetes Mellitus

Background: The purpose of this study was to compare the effectiveness of once-daily versus twice-daily insulin detemir injection in children with type 1 diabetes mellitus (T1DM). Methods: In this randomized 4-month clinical trial, 60 children aged 33 - 156 months with T1DM were randomly assigned into two groups, once-daily (group 1) and twice-daily (group 2) detemir insulin injection with pre-meal insulin Aspart. The first month of the study was devoted to educating the patients and insulin dose titration. Hemoglobin A1C (HbA1C) measured at the end of the first month and again after the fourth month. Hypoglycemia as one of the major complications was defined as blood glucose lower than 70 mg/dL with clinical symptoms or blood glucose lower than 50 mg/dL in the absence of clinical symptoms. Results: Mean HbA1C in the fourth month was 8.5% ± 1% in group 1 and 8.5% ± 1.1% in group 2 (P = 0.98). Mean changes in the fourth month compared to baseline were -0.09% (95% CI: -0.47 - 0.3) in group 1, and -0.42% (95% CI: -0.94 - 0.09) in group 2 (P = 0.273). The treatment modification rate was 39% and 15% in groups 1 and 2, respectively (P = 0.02). However, there were no statistically significant differences between the two groups in terms of insulin dose, hypoglycemia, and other complications. Conclusions: Twice-daily injections did not change HbA1c in comparison with once-daily injections. However, the lower treatment modification rate in the twice-daily group in the age group of our study was considerable.